Panadol Cold/flu Tablets
It is used to treat nose stuffiness.It is used to ease pain and fever.
Drug Class
Analgesic, Antipyretic, Nasal Decongestant
Pharmacologic Class
Para-aminophenol derivative (Acetaminophen), Alpha-1 adrenergic agonist (Phenylephrine)
Pregnancy Category
Category C
FDA Approved
Jan 1970
DEA Schedule
Not Controlled
Overview
What is this medicine?
This medicine contains two active ingredients: Acetaminophen, which helps relieve pain and reduce fever, and Phenylephrine, which is a decongestant that helps clear stuffy noses. It's used to treat common cold and flu symptoms like headache, body aches, fever, and nasal congestion.
How to Use This Medicine
Taking Your Medication
To use this medication correctly, follow your doctor's instructions and read all the information provided. Take your medication with or without food, but if it causes stomach upset, take it with food. Some brands of this medication must be swallowed whole, so check with your doctor or pharmacist if you're unsure about your specific brand.
Storing and Disposing of Your Medication
Store your medication at room temperature in a dry place, avoiding the bathroom. Keep all medications in a safe location, out of the reach of children and pets. Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so. If you have questions about disposal, consult your pharmacist. You may also have access to drug take-back programs in your area.
Missing a Dose
If you take this medication regularly, take a missed dose as soon as you remember. However, if it's close to the time for your next dose, skip the missed dose and resume your normal schedule. Do not take two doses at the same time or take extra doses. If you take this medication as needed, do not take it more frequently than directed by your doctor.
To use this medication correctly, follow your doctor's instructions and read all the information provided. Take your medication with or without food, but if it causes stomach upset, take it with food. Some brands of this medication must be swallowed whole, so check with your doctor or pharmacist if you're unsure about your specific brand.
Storing and Disposing of Your Medication
Store your medication at room temperature in a dry place, avoiding the bathroom. Keep all medications in a safe location, out of the reach of children and pets. Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so. If you have questions about disposal, consult your pharmacist. You may also have access to drug take-back programs in your area.
Missing a Dose
If you take this medication regularly, take a missed dose as soon as you remember. However, if it's close to the time for your next dose, skip the missed dose and resume your normal schedule. Do not take two doses at the same time or take extra doses. If you take this medication as needed, do not take it more frequently than directed by your doctor.
Lifestyle & Tips
- Stay hydrated by drinking plenty of fluids.
- Get adequate rest.
- Avoid alcohol while taking this medication.
- Do not take with other acetaminophen-containing products to avoid accidental overdose.
- Do not take with other decongestants (e.g., pseudoephedrine) or cold/flu medications without consulting a doctor or pharmacist.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
500 mg Acetaminophen / 10 mg Phenylephrine per tablet. Take 2 tablets every 4-6 hours as needed. Do not exceed 8 tablets (4000 mg Acetaminophen) in 24 hours.
Dose Range:
1000 - 4000 mg
Condition-Specific Dosing:
max_single_dose_acetaminophen:
1000 mg
max_daily_dose_acetaminophen:
4000 mg
max_daily_dose_phenylephrine:
60 mg
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not recommended for children under 12 years of age for this combination product. For children 6-11 years, specific pediatric formulations of acetaminophen and phenylephrine may be available, but not this combination.
Adolescent:
12 years and older: Same as adult dosing.
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment for phenylephrine. Acetaminophen: Use with caution, consider extending dosing interval.
Moderate:
Acetaminophen: Extend dosing interval to every 6-8 hours. Phenylephrine: Use with caution, monitor blood pressure.
Severe:
Acetaminophen: Extend dosing interval to every 8 hours. Phenylephrine: Contraindicated or use with extreme caution due to risk of hypertension.
Dialysis:
Acetaminophen: Administer after dialysis. Phenylephrine: Not significantly dialyzable, use with caution.
Hepatic Impairment:
Mild:
Acetaminophen: Use with caution, consider reduced dose or extended interval. Phenylephrine: No specific adjustment.
Moderate:
Acetaminophen: Contraindicated or use with extreme caution, significantly reduced dose and extended interval may be necessary. Phenylephrine: No specific adjustment.
Severe:
Acetaminophen: Contraindicated. Phenylephrine: No specific adjustment.
Pharmacology
Mechanism of Action
Acetaminophen: Exerts analgesic and antipyretic effects by inhibiting prostaglandin synthesis, primarily in the central nervous system. It is thought to act through a central mechanism involving COX-3 or other pathways. Phenylephrine: A selective alpha-1 adrenergic receptor agonist that causes vasoconstriction in the nasal mucosa, leading to reduced swelling and congestion.
Pharmacokinetics
Absorption:
Bioavailability:
Acetaminophen: 60-90%; Phenylephrine: ~38% (oral)
Tmax:
Acetaminophen: 0.5-2 hours; Phenylephrine: 1-2 hours
FoodEffect:
Acetaminophen: May delay absorption but not extent; Phenylephrine: No significant effect on extent of absorption.
Distribution:
Vd:
Acetaminophen: 0.95 L/kg; Phenylephrine: 200-350 L
ProteinBinding:
Acetaminophen: 10-25%; Phenylephrine: Not extensively protein bound
CnssPenetration:
Acetaminophen: Yes (readily); Phenylephrine: Limited
Elimination:
HalfLife:
Acetaminophen: 1.5-3 hours (prolonged in liver disease); Phenylephrine: 2-3 hours
Clearance:
Acetaminophen: 5 mL/min/kg; Phenylephrine: Not readily available for oral
ExcretionRoute:
Acetaminophen: Renal (as metabolites); Phenylephrine: Renal (as metabolites and unchanged drug)
Unchanged:
Acetaminophen: <5%; Phenylephrine: ~2.6% (oral)
Pharmacodynamics
OnsetOfAction:
Acetaminophen: 30-60 minutes; Phenylephrine: 15-30 minutes
PeakEffect:
Acetaminophen: 1-2 hours; Phenylephrine: 1-2 hours
DurationOfAction:
Acetaminophen: 4-6 hours; Phenylephrine: 4-6 hours
Safety & Warnings
BLACK BOX WARNING
Acetaminophen: Risk of severe liver damage. The risk of severe liver damage is increased if you take more than the recommended dose, take with other acetaminophen-containing products, or drink 3 or more alcoholic drinks every day while using this product. Risk of severe skin reactions (Stevens-Johnson Syndrome, Toxic Epidermal Necrolysis, Acute Generalized Exanthematous Pustulosis).
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing
+ Tightness in the chest or throat
+ Difficulty breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of liver problems, including:
+ Dark urine
+ Fatigue
+ Decreased appetite
+ Upset stomach or stomach pain
+ Light-colored stools
+ Vomiting
+ Yellow skin or eyes
Urination problems, such as:
+ Inability to pass urine
+ Changes in urine output
Severe skin reactions (Stevens-Johnson syndrome/toxic epidermal necrolysis), characterized by:
+ Red, swollen, blistered, or peeling skin (with or without fever)
+ Red or irritated eyes
+ Sores in the mouth, throat, nose, or eyes
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other symptoms that bother you or persist, contact your doctor:
Dizziness
Feeling nervous and excitable
* Trouble sleeping
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing
+ Tightness in the chest or throat
+ Difficulty breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of liver problems, including:
+ Dark urine
+ Fatigue
+ Decreased appetite
+ Upset stomach or stomach pain
+ Light-colored stools
+ Vomiting
+ Yellow skin or eyes
Urination problems, such as:
+ Inability to pass urine
+ Changes in urine output
Severe skin reactions (Stevens-Johnson syndrome/toxic epidermal necrolysis), characterized by:
+ Red, swollen, blistered, or peeling skin (with or without fever)
+ Red or irritated eyes
+ Sores in the mouth, throat, nose, or eyes
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other symptoms that bother you or persist, contact your doctor:
Dizziness
Feeling nervous and excitable
* Trouble sleeping
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Signs of liver damage: yellowing of skin or eyes (jaundice), dark urine, clay-colored stools, severe stomach pain, nausea, vomiting, unusual tiredness.
- Signs of severe allergic reaction: rash, itching, hives, swelling of the face/lips/tongue/throat, severe dizziness, trouble breathing.
- Signs of severe skin reactions: blistering, peeling, or red skin rash.
- Signs of cardiovascular issues: chest pain, rapid or irregular heartbeat, severe dizziness, persistent headache, nervousness, tremors, difficulty sleeping.
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
If you have liver disease, as this may affect the medication's safety and efficacy.
If you have taken certain medications for depression or Parkinson's disease within the last 14 days, including isocarboxazid, phenelzine, tranylcypromine, selegiline, or rasagiline. Taking these medications with this drug can increase the risk of very high blood pressure.
If you are currently taking linezolid or methylene blue, as these medications can interact with this drug.
This list is not exhaustive, and it is crucial to discuss all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, with your doctor and pharmacist. They will help you determine if it is safe to take this medication with your existing medications and health conditions.
Remember, do not start, stop, or change the dose of any medication without first consulting your doctor to ensure your safety.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
If you have liver disease, as this may affect the medication's safety and efficacy.
If you have taken certain medications for depression or Parkinson's disease within the last 14 days, including isocarboxazid, phenelzine, tranylcypromine, selegiline, or rasagiline. Taking these medications with this drug can increase the risk of very high blood pressure.
If you are currently taking linezolid or methylene blue, as these medications can interact with this drug.
This list is not exhaustive, and it is crucial to discuss all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, with your doctor and pharmacist. They will help you determine if it is safe to take this medication with your existing medications and health conditions.
Remember, do not start, stop, or change the dose of any medication without first consulting your doctor to ensure your safety.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. Adhere strictly to the dosage instructions provided by your doctor, as taking more than prescribed may increase your risk of experiencing severe side effects. Do not exceed the recommended treatment duration, and only take this medication for the length of time specified by your doctor.
Be cautious when taking other products that contain acetaminophen, as combining them with this medication can lead to excessive acetaminophen intake. Carefully review the labels of all medications and supplements to avoid accidental overdose. This medication contains acetaminophen, which can cause liver problems, including severe cases that may require a liver transplant or result in death. The majority of these incidents occurred in individuals who took more than 4,000 milligrams (mg) of acetaminophen per day, often in combination with multiple products containing acetaminophen.
To minimize the risk of liver problems, follow the dosage instructions precisely and do not exceed the recommended daily intake of acetaminophen. If you are unsure about the safe daily limit, consult your doctor or pharmacist. While some individuals may be advised to take up to 4,000 mg per day, others, such as those with liver problems or children, may require lower doses. If you suspect you have taken too much acetaminophen, contact your doctor immediately, even if you do not exhibit any symptoms.
Before consuming alcohol, discuss the potential risks with your doctor. Additionally, inform all your healthcare providers and laboratory personnel that you are taking this medication, as it may affect the results of certain lab tests.
This medication may not be suitable for children of all ages, so consult with your doctor before administering it to a child. If you are pregnant, planning to become pregnant, or breastfeeding, discuss the potential benefits and risks with your doctor to ensure the best possible outcome for you and your baby.
Be cautious when taking other products that contain acetaminophen, as combining them with this medication can lead to excessive acetaminophen intake. Carefully review the labels of all medications and supplements to avoid accidental overdose. This medication contains acetaminophen, which can cause liver problems, including severe cases that may require a liver transplant or result in death. The majority of these incidents occurred in individuals who took more than 4,000 milligrams (mg) of acetaminophen per day, often in combination with multiple products containing acetaminophen.
To minimize the risk of liver problems, follow the dosage instructions precisely and do not exceed the recommended daily intake of acetaminophen. If you are unsure about the safe daily limit, consult your doctor or pharmacist. While some individuals may be advised to take up to 4,000 mg per day, others, such as those with liver problems or children, may require lower doses. If you suspect you have taken too much acetaminophen, contact your doctor immediately, even if you do not exhibit any symptoms.
Before consuming alcohol, discuss the potential risks with your doctor. Additionally, inform all your healthcare providers and laboratory personnel that you are taking this medication, as it may affect the results of certain lab tests.
This medication may not be suitable for children of all ages, so consult with your doctor before administering it to a child. If you are pregnant, planning to become pregnant, or breastfeeding, discuss the potential benefits and risks with your doctor to ensure the best possible outcome for you and your baby.
Overdose Information
Overdose Symptoms:
- Acetaminophen: Nausea, vomiting, stomach pain, loss of appetite, sweating, extreme tiredness, yellowing of the skin or eyes, dark urine.
- Phenylephrine: Severe headache, dizziness, nervousness, insomnia, tremors, seizures, severe increase in blood pressure, palpitations, irregular heartbeat.
What to Do:
Seek immediate medical attention. Call 911 or Poison Control at 1-800-222-1222. Overdose of acetaminophen can cause irreversible liver damage if not treated promptly.
Drug Interactions
Contraindicated Interactions
- Monoamine Oxidase Inhibitors (MAOIs) (e.g., phenelzine, selegiline, tranylcypromine, isocarboxazid) - risk of hypertensive crisis with phenylephrine. Do not use within 14 days of MAOI discontinuation.
- Other sympathomimetics (e.g., pseudoephedrine, ephedrine) - increased risk of cardiovascular effects.
Major Interactions
- Warfarin (Acetaminophen) - increased INR and bleeding risk with chronic high doses of acetaminophen.
- Alcohol (Acetaminophen) - increased risk of hepatotoxicity.
- Beta-blockers (Phenylephrine) - may reduce antihypertensive effect of beta-blockers and increase risk of hypertension.
- Tricyclic Antidepressants (TCAs) (Phenylephrine) - may potentiate pressor effects of phenylephrine.
- Digoxin (Phenylephrine) - increased risk of arrhythmias.
Moderate Interactions
- Anticonvulsants (e.g., carbamazepine, phenytoin, phenobarbital) (Acetaminophen) - increased risk of hepatotoxicity due to enzyme induction.
- Cholestyramine (Acetaminophen) - reduces acetaminophen absorption.
- Metoclopramide/Domperidone (Acetaminophen) - increases acetaminophen absorption rate.
- Ergot alkaloids (Phenylephrine) - increased risk of vasoconstriction.
Minor Interactions
- Oral contraceptives (Acetaminophen) - may slightly reduce acetaminophen clearance.
- Caffeine (Acetaminophen) - may enhance analgesic effect.
Monitoring
Baseline Monitoring
Medical history (especially liver disease, hypertension, heart disease, thyroid disease, diabetes, glaucoma)
Rationale: To identify contraindications or conditions requiring caution.
Timing: Prior to initiation
Routine Monitoring
Symptom relief and adverse effects
Frequency: Daily, as needed
Target: Resolution of cold/flu symptoms (e.g., fever, pain, congestion)
Action Threshold: Lack of efficacy after 7 days (5 days for children), worsening symptoms, or onset of severe adverse effects (e.g., severe rash, jaundice, chest pain, palpitations, severe dizziness, persistent headache).
Blood pressure (for patients with pre-existing hypertension or risk factors)
Frequency: Periodically during use, especially with higher doses or prolonged use
Target: Within patient's normal range
Action Threshold: Significant increase in blood pressure, especially if symptomatic (e.g., headache, dizziness).
Symptom Monitoring
- Fever
- Pain (headache, body aches)
- Nasal congestion
- Runny nose
- Sore throat
- Cough (if present, though this product doesn't directly treat cough)
- Signs of liver damage (yellowing of skin/eyes, dark urine, abdominal pain, unusual tiredness)
- Signs of cardiovascular effects (palpitations, chest pain, dizziness, nervousness, insomnia)
- Allergic reactions (rash, itching, swelling, severe dizziness, trouble breathing)
Special Patient Groups
Pregnancy
Acetaminophen is generally considered safe for use during pregnancy when used at recommended doses. Phenylephrine is generally avoided, especially in the first trimester, due to potential vasoconstrictive effects that could affect uterine blood flow, though data are limited. Use only if clearly needed and under medical advice.
Trimester-Specific Risks:
First Trimester:
Phenylephrine: Potential theoretical risk of reduced uterine blood flow; generally avoided. Acetaminophen: Low risk.
Second Trimester:
Phenylephrine: Use with caution, generally avoided. Acetaminophen: Low risk.
Third Trimester:
Phenylephrine: Use with caution, generally avoided due to potential for maternal hypertension and fetal distress. Acetaminophen: Low risk.
Lactation
Acetaminophen is considered compatible with breastfeeding. Phenylephrine is excreted into breast milk in small amounts and may cause irritability or sleep disturbances in the infant, or reduce milk supply in the mother. Use with caution and monitor infant for adverse effects.
Infant Risk:
Acetaminophen: L1 (safest); Phenylephrine: L3 (moderately safe, monitor infant).
Pediatric Use
Not recommended for children under 12 years of age for this specific combination product due to the phenylephrine component. Always use pediatric-specific formulations and dosing for younger children. Risk of accidental overdose with acetaminophen is higher in children.
Geriatric Use
Use with caution in elderly patients, especially those with pre-existing cardiovascular conditions (hypertension, heart disease), diabetes, or glaucoma, as they may be more susceptible to the adverse effects of phenylephrine (e.g., increased blood pressure, nervousness, insomnia). Start with lower doses and monitor closely.
Clinical Information
Clinical Pearls
- Always check the active ingredients of other medications (especially cold/flu remedies) to avoid accidental acetaminophen overdose.
- Advise patients with hypertension, heart disease, diabetes, or thyroid disease to consult a doctor before using products containing phenylephrine.
- Phenylephrine is less effective orally as a decongestant compared to pseudoephedrine, but it is available OTC without restriction.
- Educate patients on the signs of liver toxicity and the importance of not exceeding the maximum daily dose of acetaminophen.
- This product treats symptoms, not the underlying cause of cold/flu. Encourage supportive care like rest and fluids.
Alternative Therapies
- Single-ingredient Acetaminophen for pain/fever
- Single-ingredient Phenylephrine (nasal spray or oral) for congestion
- Nasal saline sprays for congestion
- Non-pharmacological interventions (rest, hydration, humidifiers)
Cost & Coverage
Average Cost:
$5 - $15 per 20-50 tablets
Generic Available:
Yes
Insurance Coverage:
Over-the-counter (OTC) products are generally not covered by prescription drug plans, but may be eligible for FSA/HSA reimbursement.
General Drug Facts
If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so be sure to check with your pharmacist for more details. If you have any questions or concerns about your medication, don't hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek medical attention. When seeking help, be prepared to provide information about the medication taken, the amount, and the time it happened.